API Manufacturing Technician I

Novo Nordisk A/S; Powhatan (NC); On-site; USD 50,000 - 80,000; Full time

Benefits offered by this job

Leading pay and bonus

14 paid holidays

Health insurance

Dental insurance

Vision insurance

401K with company match

Parental & family leave

Product samples access

Tuition assistance

Life & disability insurance

Employee referrals

Job summary

Novo Nordisk A/S in Clayton, NC is seeking an API Manufacturing Operator to run highly automated production lines and ensure production goals are met. The role requires strict adherence to GMP and SOPs, with real-time review of batch records and active participation in equipment qualification and maintenance.

The successful candidate will have a high school diploma or equivalent, with an associate degree preferred, and at least 2 years of FDA-regulated manufacturing experience.

Qualifications

• High school graduate or equivalent
• Associate degree or higher preferred
• BioWork or equivalent training with experience preferred
• Minimum two years of manufacturing experience in FDA regulated environment preferred
• Experience solving problems using data and facts; documented investigation and rapid resolution
• Ability to read and follow SOPs and raise issues when errors are found
• Experience following safety guidelines and SOPs

Responsibilities

• Operate API manufacturing equipment to achieve production goals
• Follow GMP documentation and product quality requirements
• Review SOPs and related documents as required
• Real-time review of electronic batch records ensuring compliance to SOPs and cGMP standards
• Manage individual training plan
• Participate in qualification and validation activities as required
• Setup, operate, monitor, and control highly automated processes and systems
• Load and unload product from trucks and ISO containers as required
• Execute production schedule to achieve production goals
• Assist in troubleshooting and maintenance of equipment
• Maintain clean room areas and environmental monitoring as required
• Other accountabilities, as assigned

Skills

Problem solving

Attention to detail

Team collaboration

Safety awareness

Reading SOPs

Education

High school diploma

Associate's degree preferred

BioWork training

Tools

Microsoft Office

Lean manufacturing

Barcode systems

CGMP systems

Job description

Novo Nordisk A/S in Clayton, NC is seeking an API Manufacturing Operator to run highly automated production lines and ensure production goals are met. The role requires strict adherence to GMP and SOPs, with real-time review of batch records and active participation in equipment qualification and maintenance.

The successful candidate will have a high school diploma or equivalent, with an associate degree preferred, and at least 2 years of FDA-regulated manufacturing experience.